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FDA calls for heart, stroke warnings on 'Low T' meds

The FDA has spoken again on "Low T" drugs, and the news isn't good for drugmakers. The agency is demanding new warnings about potential heart attack and stroke risks, and advises docs not to prescribe them for age-related symptoms.

Companies have until next Tuesday to respond to the agency's request. Exact wording for the labeling will be fleshed out over time, an FDA spokeswoman told The New York Times. Regulators have not yet disclosed when the new wording will take effect.

The proposed warning follows up on a September 2014 advisory panel meeting, where the FDA's outside experts voted 14-1 to restrict testosterone-replacement therapies to men with a related medical condition such as a tumor or genetic disorder. The drugs were officially approved for men with clinically low testosterone levels based on blood tests. The European Medicines Agency (EMA) followed suit in November, saying the drugs should only treat men whose testosterone levels are low because of a medical condition.

The latest FDA move could further depress sales for testosterone-raising meds from AbbVie ($ABBV) and Eli Lilly ($LLY), which have taken a hit in recent quarters. AndroGel maker AbbVie saw its sales drop 20% in Q4 2014, reaching just $230 million. And the company is bracing for generic competition for the 1% version of AndroGel this year.

Lilly is also predicting declines for its Axiron drug, dampening its already-bleak revenue forecast for 2015. "The U.S. testosterone market has declined significantly and may be headed lower, affecting our U.S. Axiron sales," Lilly CFO Derica Rice said on a guidance call in early January.

Critics have been pointing to troubling data showing an increased risk of serious adverse effects. In November 2013, a study published in the Journal of the American Medical Association (JAMA) found a 29% increase in rates of heart attack, death and stroke among testosterone users compared with those who did not take the hormone therapy. And as the accompanying editorial pointed out, men often used testosterone for lifestyle reasons, rather than compensating for clinically low levels of the hormone.

But even as the mainstream medical community shies away from the meds, specialized clinics are seeing an lucrative opportunity. Niche clinics that distribute the drugs are cropping up across the U.S., promoting testosterone as an antidote to low energy, reduced muscle mass and sex drive--just the sort of uses the FDA now wants to warn against.